Airway Devices, Tube Securing Devices, and Methods of Making and Using the Same

ABSTRACT

Airway devices and tube securing devices are disclosed. Methods of making and using airway devices and tube securing devices are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the benefit of priority to (i) U.S.Provisional Patent Application Ser. No. 60/923,548 filed on Apr. 16,2007 and entitled “SUPRAGLOTTIC AIRWAY LARYNGOPHARYNGEAL TUBE” and (ii)U.S. patent application Ser. No. 12/104,075 filed on Apr. 16, 2008 andentitled “AIRWAY DEVICES AND METHODS OF MAKING AND USING THE SAME,” thesubject matter of both of which is hereby incorporated by reference intheir entirety.

TECHNICAL FIELD

The present invention relates to airway devices including devicesreferred to as supraglottic airway laryngopharyngeal tubes (SALTs) ororopharyngeal airway tubes. The present invention also relates to tubesecuring devices that may be used in combination with an endotrachealtube to secure a position of the endotracheal tube within an airwaydevice. The present invention further relates to methods of making andusing airway devices and tube securing devices.

BACKGROUND OF THE INVENTION

Oropharyngeal airways are designed to provide an airway for patients whoare unconscious or comatose and are unable to maintain an airway ontheir own because of an unintact gag reflex. An oropharyngeal airway isinserted into the patient's oropharynx and restrains the tongue fromretracting and occluding the glottic opening.

The traditional procedure of endotracheal intubation is typicallyaccomplished in an emergency setting by visualizing the glottic openingwith the utilization of a laryngoscope, and then advancing anendotracheal tube through the glottic opening. In the emergency setting,obstacles such as vomitus, blood, or patient positioning can makevisualization of the glottic opening extremely difficult if notimpossible. Even when aggressive oropharyngeal suctioning is applied,visualization of the glottic opening often fails to be accomplished. Ifa patient's airway cannot be rapidly and effectively secured, thepatient will become hypoxic, which results in rapid deterioration of thepatient's health and often results in death.

Given the need for quick action and the difficulty, in some cases, ofbeing able to visually detect the glottic opening of a patient, a numberof devices have been developed that do not require visualization of theglottic opening. Such devices have existed for years, but still sufferfrom one or more drawbacks. For example, the tracheal guide disclosed inU.S. Pat. No. 5,720,275 comprises a distal end in the form of ashovel-like tongue (25) and ears (18,33) positioned along opposite sidesof a U-shaped passage (17). In order to operate correctly, the disclosedtracheal guide must be precisely positioned within a patient so thatears (18,33) extend into the piriform fossa (19,34) of the patient, thepiriform fossa (19,34) being located in the vicinity of the glotticopening (39) as shown in FIGS. 1-4. In many emergency situations, suchprecise positioning is not practical given the state of the patient andthe need to act quickly.

Further, once a tracheal guide is properly positioned, an endotrachealtube is inserted through the tracheal guide and guided into the tracheaof the patient. Once the endotracheal tube is properly positioned, anair source is connected to the endotracheal tube so that air may beadministered to the patient.

What is needed in the art is a simple airway device that is (1) capableof quickly aligning certain anatomical structures of a patient's airwayso as to provide a guided pathway for an endotracheal tube to beinserted through the device and guided into the trachea of the patient,and (2) can be inserted into a patient without the need for precisepositioning of device components/features. What is also needed in theart is a simple tube securing device that is capable of securing aportion of an endotracheal tube extending from a patient's mouth toprevent undesirable movement of the endotracheal tube extending from thepatient's mouth.

SUMMARY OF THE INVENTION

The present invention is directed to airway devices that are capable ofquickly aligning certain anatomical structures of a patient's airway soas to provide a guided pathway for an endotracheal tube to be insertedthrough the device and guided into the trachea of the patient. Thedisclosed devices can be inserted into a patient without the need forprecise positioning of device components/features during insertion ofthe device.

In one exemplary embodiment, the present invention is directed to anairway device comprising a tubular member having a proximal end, adistal end opposite the proximal end, a tubular conduit positionedbetween the proximal end and the distal end, and a channel extendingfrom a first channel opening at the proximal end through the tubularconduit to a second channel opening proximate the distal end. In thisexemplary embodiment, the distal end of the device has an overall distalend width bound by opposing side walls, an overall distal end heightbound by an uppermost distal end surface and a lower distal end surface,and a tear-drop shape represented by the uppermost distal end surface,the lower distal end surface, and a curved distal end surface connectingthe uppermost distal end surface to the lower distal end surface,wherein the curved distal end surface extends substantiallyperpendicular to and between the opposing side walls. The tear-dropshape and outer dimensions of the device enable quick insertion of thedevice into a patient's mouth until the curved distal end surface of thedevice abuts corniculate cartilage of the patient.

In a further exemplary embodiment, the present invention is directed toan airway device comprising a tubular member having a proximal end, adistal end opposite the proximal end, a tubular conduit positionedbetween the proximal end and the distal end, and a channel extendingfrom a first channel opening at the proximal end through the tubularconduit to a second channel opening proximate the distal end; and anepiglottis guard extending along an upper portion of the tubular member.In this exemplary embodiment, the epiglottis guard comprises (i) a firstend that is connected to the tubular member proximate the second channelopening, (ii) a second end that is not connected to the tubular memberand is positioned between the second channel opening and the distal end,and (iii) opposing edges extending from the first end to the second end,wherein the opposing edges are not connected to the tubular member. Inthis exemplary embodiment, the second end of the epiglottis guard isoperatively adapted to move into or away from the channel, for example,during insertion of an endotracheal tube through the channel of thedevice and into a patient's trachea.

The present invention is also directed to tube securing devices that arecapable of securing an endotracheal tube to a patient. In one exemplaryembodiment, the tube securing device comprises a tube securing devicefor stabilizing a position of an endotracheal tube on a patient, whereinthe tube securing device comprises (i) an endotracheal tube clampingmember operatively adapted to clamp onto an outer surface of anendotracheal tube, the endotracheal tube clamping member comprising atleast one clamp connector positioned along an outer surface of theendotracheal tube clamping member; and (ii) a strap comprising one ormore strap connectors positioned along a length of the strap, each ofthe one or more strap connectors being independently connectable to acorresponding clamp connector.

In another exemplary embodiment, the tube securing device comprises atube securing device for stabilizing a position of an endotracheal tubeextending from a patient's mouth, wherein the tube securing devicecomprises (1) an endotracheal tube clamping member operatively adaptedto clamp onto an outer surface of an endotracheal tube, the endotrachealtube clamping member comprising (i) a closed end having a closed endinner surface and a closed end outer surface, (ii) an open end oppositethe closed end and comprising (iii) a pawling member and (iv) aratcheting member, the pawling member being movable along a row ofratcheting teeth along the ratcheting member so as to lock the pawlingmember within the ratcheting member and simultaneously clamp onto theouter surface of the endotracheal tube, and (v) a pair of clampconnectors positioned along opposite sides of the closed end outersurface, wherein each of the clamp connectors comprises amushroom-shaped member extending outward from opposite sides of theclosed end outer surface; and (2) a strap comprising (i) a strip ofmaterial having opposite strip ends, a strip width, and a strip lengthextending between the opposite strip ends, and (ii) a plurality of strapconnectors positioned along the strip length, each of the one or morestrap connectors being independently connectable to a correspondingclamp connector, wherein each strap connector comprises an openingextending through the strap. In this exemplary embodiment, the straplength enables the strap to extend from the patient's mouth, along arear portion of the patient's head or neck region, and back to thepatient's mouth so as to surround a portion of the patient's head.

The present invention is further directed to methods of making airwaydevices and tube securing devices suitable for use in an endotrachealintubation procedure. In one exemplary embodiment, the present inventionis directed to a method of making an airway device comprising forming atubular member having a proximal end, a distal end opposite the proximalend, a tubular conduit positioned between the proximal end and thedistal end, and a channel extending from a first channel opening at theproximal end through the tubular conduit to a second channel openingproximate the distal end, wherein the distal end of the device has anoverall distal end width bound by opposing side walls, an overall distalend height bound by an uppermost distal end surface and a lower distalend surface, and a tear-drop shape represented by the uppermost distalend surface, the lower distal end surface, and a curved distal endsurface connecting the uppermost distal end surface to the lower distalend surface, wherein the curved distal end surface extends substantiallyperpendicular to and between the opposing side walls. In this exemplaryembodiment, the forming step may comprise a single thermoforming step(e.g., a single molding step) or may comprise a single thermoformingstep in combination with other possible method steps.

In a further exemplary embodiment, the present invention is directed toa method of making an airway device comprising forming a tubular memberhaving a proximal end, a distal end opposite the proximal end, a tubularconduit positioned between the proximal end and the distal end, achannel extending from a first channel opening at the proximal endthrough the tubular conduit to a second channel opening proximate thedistal end, and an epiglottis guard extending along an upper portion ofthe tubular member. In this exemplary embodiment, the forming step maycomprise a single thermoforming step (e.g., a single molding step) ormay comprise a thermoforming step (e.g., for forming the tubular member)in combination with one or more other method steps. For example, theepiglottis guard may be formed by cutting an upper portion of thetubular member extending over the channel so as to form an epiglottisguard comprising (i) a first end that is connected to the tubular memberproximate the second channel opening, (ii) a second end that is notconnected to the tubular member and is positioned between the secondchannel opening and the distal end, and (iii) opposing cut edgesextending from the second end to the first end, wherein the second endof the epiglottis guard is operatively adapted to move into or away fromthe channel, for example, during insertion of an endotracheal tubethrough the channel of the device and into a patient's trachea.

The present invention is also directed to methods of making a tubesecuring device. In one exemplary embodiment, the method of making atube securing device comprises (i) forming an endotracheal tube clampingmember operatively adapted to clamp onto an outer surface of anendotracheal tube, the endotracheal tube clamping member comprising atleast one clamp connector positioned along an outer surface of theendotracheal tube clamping member; and (ii) forming a strap comprisingone or more strap connectors positioned along a length of the strap,each of the one or more strap connectors are independently connectableto a corresponding clamp connector. In this exemplary embodiment, eachforming step may comprise independent thermoforming steps (e.g., amolding step for forming the endotracheal tube clamping member and anextrusion step for forming the strap).

The present invention is even further directed to methods of usingairway devices and tube securing devices in an endotracheal intubationprocedure. In one exemplary embodiment, the present invention isdirected to a method of inserting an endotracheal tube into a trachea ofa patient comprising the steps of inserting an airway device into thepatient's mouth until a curved distal end surface of the device abutscorniculate cartilage of the patient, the device comprising a tubularmember having a proximal end, a distal end opposite the proximal end, atubular conduit positioned between the proximal end and the distal end,and a channel extending from a first channel opening at the proximal endthrough the tubular conduit to a second channel opening proximate thedistal end, wherein the distal end has an overall distal end width boundby opposing side walls, an overall distal end height bound by anuppermost distal end surface and a lower distal end surface, and atear-drop shape represented by the uppermost distal end surface, thelower distal end surface, and the curved distal end surface connectingthe uppermost distal end surface to the lower distal end surface, thecurved distal end surface extending substantially perpendicular to andbetween the opposing side walls; and pushing an endotracheal tubethrough the channel of the device. This exemplary method may compriseone or more additional steps including, but not limited to, connecting aventilation mask to the proximate end of the device after the insertingstep, disconnecting the ventilation mask from the proximate end of thedevice after the connecting step and prior to said pushing step, coatingat least a portion of a leading end of the endotracheal tube with alubricant prior to the pushing step, and securing a portion of theendotracheal tube extending from the patient's mouth to the patient viaa tube securing device comprising an endotracheal tube clamping memberand a strap that connects to the endotracheal tube clamping member andextends around a portion of the patient's head.

The present invention is even further directed to kits suitable forperforming an endotracheal intubation procedure. In one exemplaryembodiment, the kit comprises (i) at least one of the disclosed airwaydevices in combination with (ii) an endotracheal tube. In anotherexemplary embodiment, the kit comprises (i) at least one of thedisclosed airway devices in combination with (ii) a tube securing devicecomprising an endotracheal tube clamping member and a strap that isconnectable to the endotracheal tube clamping member and extendablearound a portion of a patient's head. In a further exemplary embodiment,the kit comprises (i) a tube securing device comprising an endotrachealtube clamping member and a strap that is connectable to the endotrachealtube clamping member and extendable around a portion of a patient's headin combination with (ii) an endotracheal tube. In yet another exemplaryembodiment, the kit comprises (i) at least one of the disclosed airwaydevices in combination with (ii) an endotracheal tube, (iii) anendotracheal tube clamping member and (iv) a strap that is connectableto the endotracheal tube clamping member and extendable around a portionof a patient's head. Each of the kits of the present invention mayfurther comprise additional kit components including, but not limitedto, a lubricant, and a ventilation mask.

In one exemplary embodiment, the kit of the present invention comprises(1) a tube securing device for stabilizing a position of an endotrachealtube on a patient, wherein the tube securing device comprises (i) anendotracheal tube clamping member operatively adapted to clamp onto anouter surface of an endotracheal tube, the endotracheal tube clampingmember comprising at least one clamp connector positioned along an outersurface of the endotracheal tube clamping member; and (ii) a strapcomprising one or more strap connectors positioned along a length of thestrap, each of the one or more strap connectors being independentlyconnectable to a corresponding clamp connector; and (2) an airwaydevice, wherein the airway device comprises (a) a tubular member havinga proximal end, a distal end opposite the proximal end, a tubularconduit positioned between the proximal end and the distal end, and achannel extending from a first channel opening at the proximal endthrough the tubular conduit to a second channel opening proximate thedistal end; and (b) an epiglottis guard extending along an upper portionof the tubular member, the epiglottis guard comprising (i) a first endthat is connected to the tubular member proximate the second channelopening, (ii) a second end that is not connected to the tubular memberand positioned between the second channel opening and the distal end,and (iii) opposing edges extending from the first end to the second end,the opposing edges being not connected to the tubular member, whereinthe second end is operatively adapted to move into or away from thechannel.

These and other features and advantages of the present invention willbecome apparent after a review of the following detailed description ofthe disclosed embodiments and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is further described with reference to theappended figures, wherein:

FIG. 1 provides a perspective view of an exemplary airway device of thepresent invention;

FIG. 2 provides a side view of the exemplary airway device shown in FIG.1;

FIG. 3 provides a top view of the exemplary airway device shown in FIG.1;

FIG. 4 provides a side view of the exemplary airway device shown in FIG.1 with an endotracheal tube inserted through the exemplary airwaydevice;

FIG. 5 provides a view of the exemplary airway device shown in FIG. 1positioned within a patient during an endotracheal intubation procedure;

FIG. 6 provides a top view of another exemplary airway device of thepresent invention;

FIG. 7 provides a side view of the exemplary airway device shown in FIG.6;

FIG. 8 provides a cross-sectional view of the exemplary airway deviceshown in FIG. 6 along line B-B shown in FIG. 6;

FIG. 9 provides a rear view of a distal end of the exemplary airwaydevice shown in FIG. 6;

FIG. 10 provides a view of the exemplary airway device shown in FIG. 6positioned within a patient during an endotracheal intubation procedure;

FIG. 11 provides a view of an exemplary tube securing device of thepresent invention;

FIG. 12 provides a view of the exemplary tube securing device shown inFIG. 11 in combination with an endotracheal tube positioned within theexemplary airway device shown in FIG. 6; and

FIG. 13 provides a view of the exemplary tube securing device and airwaydevice combination shown in FIG. 12 in use on a patient.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to airway devices suitable for use inan endotracheal intubation procedure. As used herein, the phrase “airwaydevice” or “airway devices” is used to describe a class of devices thatincludes, but is not limited to, supraglottic airway laryngopharyngealtubes (SALTs) and oropharyngeal airway tubes. In particular, thedisclosed airway devices are suitable for use in procedures forproviding ventilation (e.g., air) to a patient, procedures for insertingan endotracheal tube into the trachea of a patient, or both. The presentinvention is further directed to methods of making airway devices, aswell as methods of using airway devices in an endotracheal intubationprocedure. One exemplary airway device of the present invention suitablefor use in an endotracheal intubation procedure is shown as exemplaryairway device 50 in FIG. 1.

Referring to FIG. 1, exemplary airway device 50 comprises a tubularmember 51 having a proximal end 1, a distal end 6 opposite proximal end1, a tubular conduit 3 positioned between proximal end 1 and distal end6, and a channel 31 extending from a first channel opening 35 atproximal end 1 through tubular conduit 3 to a second channel opening 34proximate distal end 6. Exemplary airway device 50 further comprises adepth indicator ring 2 proximate proximal end 1. Although shownpositioned a distance d₁ from proximal end 1, it should be understoodthat depth indicator ring 2 may be positioned at proximal end 1 (i.e.,d₁=0) or any distance d₁ from proximal end 1. Typically, depth indicatorring 2 has an outer diameter that is greater than an outer diameter oftubular conduit 3 as shown in FIG. 1. As discussed further below, depthindicator ring 2 may be used to signal a proper depth of insertion intoa patient's mouth during an endotracheal intubation procedure.

As shown in FIG. 1, distal end 6 of exemplary airway device 50 has anoverall distal end width, d_(W), bound by opposing side walls 16 and 17(see, FIG. 3), an overall distal end height, d_(H), bound by anuppermost distal end surface 13 and a lower distal end surface 14, and atear-drop shape represented by uppermost distal end surface 13, lowerdistal end surface 14, and a curved distal end surface 15 connectinguppermost distal end surface 13 to lower distal end surface 14. As shownin FIG. 1, curved distal end surface 15 extends substantiallyperpendicular to and between opposing side walls 16 and 17. In onedesired embodiment, at least a portion of each of opposing side walls 16and 17 (see, FIG. 3) proximate curved distal end surface 15 extendssubstantially parallel to one another so as to form right angles withcurved distal end surface 15. As discussed further below (and shown inFIG. 5), the tear-drop shape and outer dimensions of exemplary airwaydevice 50 enable quick insertion of exemplary airway device 50 into apatient's mouth until curved distal end surface 15 of exemplary airwaydevice 50 abuts corniculate cartilage of a patient.

In some exemplary embodiments, the airway devices of the presentinvention further comprise a pair of raised ridges that form a channelextension operatively adapted to direct an endotracheal tube along anuppermost distal end surface of the device toward a glottic opening of apatient. As shown in FIG. 1, exemplary airway device 50 comprises raisedridges 5 extending along uppermost distal end surface 13 between secondchannel opening 34 and a tip portion 7 of distal end 6. Raised ridges 5form a channel extension 36 that is operatively adapted to direct anendotracheal tube (not shown) along uppermost distal end surface 13toward a glottic opening of a patient (see, FIGS. 4-5).

Desirably, raised ridges 5 are mirror images of one another. In otherwords, a line dissecting channel extension 36 would be equally spacedfrom corresponding points along each of raised ridges 5. In someembodiments, raised ridges 5 are substantially parallel with oneanother. In other embodiments, such as shown in FIG. 1, raised ridges 5have some curvature therein. For example, raised ridges 5 may beconfigured such that a shortest distance between raised ridges 5 isalong a center portion of a given raised ridge 5 or along a portion of agiven raised ridge 5 proximate second channel opening 34 while agreatest distance between raised ridges 5 is along a portion of a givenraised ridge 5 proximate tip portion 7 of distal end 6 (see, forexample, raised ridge 5 shown in FIG. 3).

As shown in FIG. 2, exemplary airway device 50 has a curvedconfiguration. The curved configuration may be further described withreference to lines 20-20 and 21-21, as well as angle A (also referred toherein as the “angle of curvature”) formed therebetween. In one desiredembodiment, tubular member 51 has a curved section between proximal end1 and distal end 6 such that (i) a first line 21-21 extendingsubstantially parallel to tubular member 51 out of first channel opening35 (i.e., dissects first channel opening 35) and (ii) a second line20-20 extending from distal end 6 through curved distal end surface 15and positioned an equal distance from uppermost distal end surface 13and lower distal end surface 14 forms an angle A with one another ofless than 180°. Typically, angle A ranges from about 110° to about 165°,more typically, from about 130° to about 145°, and in one exemplaryembodiment, about 135°.

Further, as shown in FIG. 2, distal end 6 of exemplary airway device 50desirably provides an upward surface inclination from a lowest pointwithin second channel opening 34 to a point along uppermost distal endsurface 13. In one desired embodiment, channel 31 has a lowest channelpoint 39 along channel 31, wherein lowest channel point 39 is a firstdistance d₂ above lower distal end surface 14, and channel extension 36has a highest channel extension point 43 along uppermost distal endsurface 13, wherein highest channel extension point 43 is a seconddistance d₃ above lower distal end surface 14, wherein second distanced₃ is greater than first distance d₂. Desirably, highest channelextension point 43 comprises an uppermost point along uppermost distalend surface 13.

This surface inclination feature of exemplary airway device 50 may befurther described with reference to lines 22-22 and 23-23, as well asangle B (also referred to herein as the “angle of inclination”) formedtherebetween. In one desired embodiment, distal end 6 of exemplaryairway device 50 provides an upward surface inclination such that (i)first line 23-23 extending substantially parallel to lower distal endsurface 14 and (ii) line 22-22 extending through lowest channel point 39and along uppermost distal end surface 13 forms an angle B with oneanother of greater than about 10°. Typically, angle B ranges from about10° to about 60°, more typically, from about 25° to about 50°, and inone exemplary embodiment, about 30° to about 40°.

FIG. 3 provides a top view of exemplary airway device 50. In FIG. 3,channel 31, first channel opening 35, second channel opening 34, raisedridges 5, channel extension 36, and opposing side walls 16 and 17 aremore depicted. As shown in FIG. 3, overall distal end width d_(W) istypically greater than an overall width tc_(W) of tubular conduit 3. Asdiscussed further below, overall distal end width d_(W) functions toseat exemplary airway device 50 against corniculate cartilage of apatient when positioned within the patient's orophamyx without anyportion of exemplary airway device 50 extending into the esophagus orpiriform fossa of the patient.

Exemplary airway device 50 may be used in combination with anendotracheal tube during an endotracheal intubation procedure. FIG. 4provides a side view of exemplary airway device 50 in combination withan endotracheal tube 8 inserted through channel 31 of exemplary airwaydevice 50. As shown in FIG. 4, endotracheal tube 8 extends throughchannel 31 of exemplary airway device 50, out of second channel opening34 and along channel extension 36 between raised ridges 5 alonguppermost distal end surface 13. FIG. 5 provides a view of exemplaryairway device 50 in combination with endotracheal tube 8 as positionedwithin a patient 44 during an endotracheal intubation procedure.

As shown in FIG. 5, exemplary airway device 50 extends from out of mouth45 of patient 44 to corniculate cartilage 46 proximate the opening intothe esophagus 12 of patient 44. Distal end tip 7 of distal end 6 abutscorniculate cartilage 46 so as to position second channel opening 34proximate glottic opening 10 leading into the trachea 11 of patient 44.Overall distal end height, d_(H), of distal end 6 prevents exemplaryairway device 50 from extending beyond corniculate cartilage 46 and intoesophagus 12. (Note that lower distal end surface 14 is in contact withthroat wall 47 so as to lodge distal end 6 against corniculate cartilage46.) Endotracheal tube 8 extends through channel 31 of exemplary airwaydevice 50, out of second channel opening 34, along channel extension 36between raised ridges 5 and along uppermost distal end surface 13,through glottic opening 10 and into trachea 11 of patient 44.

FIG. 6 provides a top view of another exemplary airway device 60 of thepresent invention. As shown in FIG. 6, exemplary airway device 60comprises tubular member 61 having a proximal end 1, a distal end 6opposite proximal end 1, a tubular conduit 3 positioned between proximalend 1 and distal end 6, and a channel 31 extending from a first channelopening 35 at proximal end 1 through tubular conduit 3 to a secondchannel opening 34 proximate distal end 6. Exemplary airway device 60further comprises an epiglottis guard 30 extending along an upperportion 62 of tubular member 61, wherein epiglottis guard 30 comprises(i) a first end 63 that is connected to tubular member 61 proximatesecond channel opening 34, (ii) a second end 64 that is not connected totubular member 61 and is positioned between second channel opening 34and distal end 6, and (iii) opposing edges 65 and 66 extending fromfirst end 63 to second end 64, wherein opposing edges 65 and 66 are notconnected to tubular member 61, and second end 64 is operatively adaptedto move into or away from channel 31 (see, for example, possiblemovement of second end 64 as shown in FIG. 8).

Epiglottis guard 30 has a guard length, g_(L), extending the length ofopposing edges 65 and 66. Guard length, g_(L), may vary as desired, buttypically guard length, g_(L), extends a distance that is less than orequal to a distance from proximate second channel opening 34 to an endpoint 33 of channel 31. More typically, guard length, g_(L), extends adistance that is about half the distance from proximate second channelopening 34 to end point 33 of channel 31. In dimensions, guard length,g_(L), typically ranges from about 1.3 centimeters (cm) (0.5 inches(in)) to about 3.8 cm (1.5 in) in length.

As shown in FIG. 6, distal end 6 of exemplary airway device 60 has anoverall distal end width, d_(W), bound by opposing side walls 16 and 17.As shown in FIG. 7, distal end 6 of exemplary airway device 60 has anoverall distal end height, d_(H), bound by uppermost distal end surface13 and lower distal end surface 14, and a tear-drop shape represented byuppermost distal end surface 13, lower distal end surface 14, and acurved distal end surface 15 connecting uppermost distal end surface 13to lower distal end surface 14. (The intersection of uppermost distalend surface 13 and curved distal end surface 15 being depicted asjunction 76.) Desirably, curved distal end surface 15 extendssubstantially perpendicular to and between opposing side walls 16 and 17(see, FIG. 6). Similar to exemplary airway device 50 discussed above,the tear-drop shape and outer dimensions of exemplary airway device 60enable quick insertion of exemplary airway device 60 into a patient'smouth until curved distal end surface 15 of exemplary airway device 60abuts corniculate cartilage of a patient (as shown in FIG. 10).

FIG. 7 provides a side view of exemplary airway device 60 shown in FIG.6. As shown in FIG. 7, exemplary airway device 60 desirably has a curvedconfiguration. The curved configuration may be further described withreference to lines 20-20 and 21-21, as well as angle A (i.e., angle ofcurvature) formed therebetween. In one desired embodiment, tubularmember 61 has a curved section between proximal end 1 and distal end 6such that (i) a first line 21-21 extending substantially parallel totubular member 61 out of first channel opening 35 (i.e., dissects firstchannel opening 35) and (ii) a second line 20-20 extending from distalend 6 through curved distal end surface 15 and positioned an equaldistance from uppermost distal end surface 13 and lower distal endsurface 14 forms an angle A with one another of less than 180°.Typically, angle A ranges from about 110° to about 165°, more typically,from about 130° to about 145°, and in one exemplary embodiment, about140°.

FIG. 8 provides a cross-sectional view of exemplary airway device 60shown in FIG. 6 along line B-B shown in FIG. 6. As shown in FIG. 8,channel 31 extends from first channel opening 35 along tubular member 61through second channel opening 34 to end point 33. As shown in FIG. 8,first channel opening 35 may have an opening inner diameter slightlylarger than an inner diameter of tubular conduit 3.

Further, as shown in FIG. 8, distal end 6 of exemplary airway device 60desirably provides an upward surface inclination from second channelopening 34 to a point along uppermost distal end surface 13. In onedesired embodiment, channel 31 has a lowest channel point 32 alongchannel 31, wherein lowest channel point 32 is a first distance d₂ abovelower distal end surface 14, and channel 31 has a highest channel pointat end point 33 along uppermost distal end surface 13 or curved distalend surface 15, wherein end point 33 is a second distance d₃ above lowerdistal end surface 14, wherein second distance d₃ is greater than firstdistance d₂.

This feature of exemplary airway device 60 may be further described withreference to lines 84-84 and 85-85, as well as angle C (also referred toherein as the “angle of inclination”) formed therebetween. In onedesired embodiment, distal end 6 of exemplary airway device 60 providesan upward surface inclination such that (i) first line 85-85 extendingsubstantially parallel to lower distal end surface 14 and (ii) line84-84 extending through lowest channel point 32 and through end point 33forms an angle C with one another of greater than about 10°. Typically,angle C ranges from about 10° to about 60°, more typically, from about25° to about 50°, and in one exemplary embodiment, about 30° to about40°.

As shown in FIG. 8 and discussed above, second end 64 of epiglottisguard 30 is operatively adapted to move into or away from channel 31 asdesignated by up and down arrows F. As discussed further below withreference to FIG. 10, epiglottis guard 30 prevents the epiglottis of apatient from blocking the glottic opening during an endotrachealintubation procedure.

FIG. 9 provides a rear view of distal end 6 of exemplary airway device60 shown in FIG. 6. As shown in FIG. 9, lower distal end surface 14 mayhave one or more fluid distribution channels 70 extending along a lengthof lower distal end surface 14. Typically, fluid distribution channels70 are oriented so as to extend from a location proximate second channelopening 34 to a location proximate a junction 75 between lower distalend surface 14 and curved distal end surface 15. Each of fluiddistribution channels 70 may have dimensions that vary depending on theouter dimensions of distal end 6. A depth of a given fluid distributionchannel 70 (i.e., the dimension extending into the page) may be constantalong a length of fluid distribution channel 70 or may vary along alength of fluid distribution channel 70. In one exemplary embodiment,the depth of each of the fluid distribution channels 70 increases fromlocation 71 to location 72 within a given fluid distribution channel 70so as to follow along the inclination angle of channel 31 (e.g., angle Cshown in FIG. 8). In another exemplary embodiment, the depth of each ofthe fluid distribution channels 70 is substantially the same fromlocation 71 to location 72 within a given fluid distribution channel 70.

It should be understood that fluid distribution channels 70 are oneoptional feature for distal end 6 of exemplary airway device 50 and/or60, and are not required. The presence of fluid distribution channels 70may provide one or more advantages (i) to the resulting device (e.g.,enhanced structural stability at the distal end), (ii) during use (e.g.,enhanced fluid flow within a patient's throat), as well as (iii) duringmanufacturing (e.g., reduces mold element thickness of any given portionof the distal end using an injection molding step).

FIG. 10 provides a view of exemplary airway device 60 in combinationwith endotracheal tube 8 as positioned within a patient 44 during anendotracheal intubation procedure. As shown in FIG. 10, exemplary airwaydevice 60 extends from out of mouth 45 of patient 44 to corniculatecartilage 46 proximate the opening into the esophagus 12 of patient 44.Distal end tip 7 of distal end 6 abuts corniculate cartilage 46 so as toposition second channel opening 34 and epiglottis guard 30 proximateglottic opening 10 leading into the trachea 11 of patient 44. Overalldistal end height, d_(H), of distal end 6 prevents exemplary airwaydevice 60 from extending beyond corniculate cartilage 46 and intoesophagus 12. (Note that lower distal end surface 14 is in contact withthroat wall 47 so as to lodge distal end 6 against corniculate cartilage46.) Endotracheal tube 8 extends through channel 31 of exemplary airwaydevice 60, out of second channel opening 34, along channel 31 and alonguppermost distal end surface 13, through glottic opening 10 and intotrachea 11 of patient 44.

As shown in FIG. 10, epiglottis guard 30 of exemplary airway device 60comes into contact with epiglottis 9 when endotracheal tube 8 extendsout of second channel opening 34. As leading end 78 of endotracheal tube8 moves out of second channel opening 34 and along uppermost distal endsurface 13, the outer dimensions of endotracheal tube 8 exert an upwardforce on second end 64 of epiglottis guard 30, causing second end 64 ofepiglottis guard 30 to push epiglottis 9 out of glottic opening 10 sothat leading end 78 of endotracheal tube 8 can move into trachea 11 ofpatient 44 without obstruction.

The above-described airway devices are desirably free from anyinflatable components. In other words, the disclosed airway devicescomprise a rigid structure that is not inflatable. Further, thedisclosed airway devices are typically free from any voids or emptyspaces other than the above-described channel (e.g., channel 31) and theabove-described optional fluid distribution channels (e.g., fluiddistribution channels 70).

In addition, the above-described tear-drop shape represented by theuppermost distal end surface, the lower distal end surface, and thecurved distal end surface connecting the uppermost distal end surface tothe lower distal end surface is described as having a curved distal endsurface that extends substantially perpendicular to and between theopposing side walls. It should be noted that the curved distal endsurface desirably extends substantially perpendicular to and between theopposing side walls continuously along an outer periphery of each of theopposing side walls. In other words, the distal end typically does notcontain any voids or empty space between the opposing side walls andalong the curved distal end surface except possibly a portion of channel31. Further, the distal end tip (e.g., tip 7) positioned along thedistal end (e.g., distal end 6) does not comprise any further extensionsbeyond curved distal end surface (e.g., curved distal end surface 15).In other words, curved distal end surface forms an outermost portion ofthe distal end tip.

Although the above-described airway devices may have any desireddimensions, typically the above-described airway devices have dimensionsas shown in the table below.

Dimension Typical Range More Typical Range overall length about 10.2 cm(4.0 in) to about 12.7 cm (5.0 in) to about 20.3 cm (8.0 in) about 17.8cm (7.0 in) distal end width, d_(W) about 2.5 cm (1.0 in) to about about3.2 cm (1.25 in) to 7.6 cm (3.0 in) about 3.8 cm (1.5 in) distal endheight, d_(H) about 1.3 cm (0.5 in) to about about 1.9 cm (0.75 in) to3.8 cm (1.5 in) about 2.5 cm (1.0 in) channel inner about 1.3 cm (0.5in) to about about 1.3 cm (0.5 in) to about diameter 3.8 cm (1.5 in) 1.9cm (0.75 in) tubular conduit outer about 1.9 cm (0.75 in) to about 1.9cm (0.75 in) to diameter about 5.1 cm (2.0 in) about 2.5 cm (1.0 in)length of depth about 0.8 cm (0.3 in) to about about 0.8 cm (0.3 in) toabout indicator ring 2.5 cm (1.0 in) 1.3 cm (0.5 in) tubular conduitwall about 0.25 cm (0.10 in) to about 0.25 cm (0.10 in) to thicknessabout 0.63 cm (0.25 in) about 0.51 cm (0.20 in) wall thickness of about0.25 cm (0.10 in) to about 0.51 cm (0.20 in) to depth indicator ringabout 0.95 cm (0.375 in) about 0.8 cm (0.3 in) length of epiglottisabout 1.3 cm (0.5 in) to about about 1.9 cm (0.75 in) to guard 6.3 cm(2.5 in) about 3.8 cm (1.5 in) angle of curvature about 110° to about170° about 130° to about 150° along device (e.g., angle A shown in FIGS.2 and 7) angle of channel about 20° to about 60° about 20° to about 40°inclination (e.g., angle B shown in FIG. 2 and angle C shown in FIG. 8)

The present invention is further directed to tube securing devices thatare capable of securing an endotracheal tube to a patient. FIG. 11provides a view of an exemplary tube securing device 90 of the presentinvention. As shown in FIG. 11, exemplary tube securing device 90comprises (1) an endotracheal tube clamping member 92 operativelyadapted to clamp onto an outer surface of an endotracheal tube (notshown; see, for example, exemplary endotracheal tube 8 in FIGS. 4-5 and10), and (2) a strap 91. Endotracheal tube clamping member 92 comprisingat least one clamp connector 105 positioned along an outer surface 104of endotracheal tube clamping member 92. Strap 91 comprising one or morestrap connectors 94 positioned along a length S_(L) of strap 91, whereineach of the one or more strap connectors 94 are independentlyconnectable to a corresponding clamp connector 105 (e.g., a singlecorresponding clamp connector 105 or multiple corresponding clampconnectors 105).

As shown in FIG. 11, exemplary endotracheal tube clamping member 92comprises a closed end 101 having a closed end inner surface 103 and aclosed end outer surface 104, an open end 102 opposite closed end 104and comprising a pawling member 106 and a ratcheting member 107.Ratcheting member 107 comprises a row of ratcheting teeth 109 along aninner surface 108 of ratcheting member 107. Pawling member 106 ismovable in a direction (as shown by arrow P) so as to engage with row ofratcheting teeth 109 along an inner surface 108 of ratcheting member 107and lock pawling member 106 at a position along row of ratcheting teeth109. As pawling member 106 moves further in the P direction, exemplaryendotracheal tube clamping member 92 clamps onto an outer surface of anendotracheal tube (not shown) positioned along inner surface 103 ofclosed end 101.

To disengage exemplary endotracheal tube clamping member 92 from anendotracheal tube (not shown) positioned along inner surface 103 ofclosed end 101, a user forces ratcheting member 107 outward (e.g., in adirection shown by arrow D) so as to enable pawling member 106 todisengage with row of ratcheting teeth 109 and move in a directionopposite the P direction. Once pawling member 106 is disengaged from rowof ratcheting teeth 109, exemplary endotracheal tube clamping member 92can be removed from the endotracheal tube (not shown).

As discussed above, the endotracheal tube clamping member of the presentinvention may comprise comprising at least one clamp connector (e.g.,clamp connector 105). As shown in FIG. 11, exemplary endotracheal tubeclamping member 92 comprises a pair of clamp connectors 105 positionedalong opposite sides of closed end outer surface 104. Although eachclamp connector 105 may have any connector configuration that enablesconnection with a corresponding strap connector, in one desiredembodiment, each clamp connector 105 comprises a mushroom-shaped memberextending outward from opposite sides of closed end outer surface 104 asshown in FIG. 11. As used herein, the term “mushroom-shaped member” isused to describe a connector member comprising (i) an outermost shapedmember and a stem portion connecting the outermost shaped member to asurface (e.g., closed end outer surface 104), wherein the outermostshaped member has a cross-sectional area extending substantiallyparallel with the surface (e.g., closed end outer surface 104) that isgreater than a cross-sectional area of the stem portion.

Endotracheal tube clamping members used in the tube securing devices ofthe present invention (e.g., exemplary endotracheal tube clamping member92) may be formed using a variety of materials. Suitable materialsinclude, but are not limited to, polymeric materials such as polyester,polypropylene, and polyvinyl chloride. In one desired embodiment, theendotracheal tube clamping member used in the tube securing devices ofthe present invention is formed using polypropylene.

As shown in FIG. 11, strap 91 comprising a strip of material 93 havingopposite strip ends 95 and 96, a strip width S_(W), a strip length S_(L)extending between opposite strip ends 95 and 96, and a plurality ofstrap connectors 94 positioned along strip length S_(L). Typically,strip length S_(L) is about 10 or more (or about 15, or about 20, orabout 25, or about 30) times greater than strip width S_(W). In oneexemplary embodiment, strip width S_(W) ranges from about 0.5 cm (0.2in) to about 5.1 cm (2.0 in) (or from about 1.3 cm (0.5 in) to about 2.5cm (1.0 in)), and strip length S_(L) ranges from about 25 cm (10 in) toabout 75 cm (29.5 in) (or from about 38.1 cm (15 in) to about 63.5 cm(25 in)). In one desired embodiment, strip width S_(W) is about 1.9 cm(0.75 in), and strip length S_(L) is about 55.2 cm (21.75 in).

As with the clamp connectors discussed above, each strap connector mayhave any connector configuration that enables connection with acorresponding clamp connector. In one desired embodiment, each strapconnector 94 comprises an opening extending through strap 91, whereineach opening is dimensioned so as to fit over and engage with at leastone clamp connector, such as exemplary clamp connectors 105 having aconfiguration in the form of mushroom-shaped members.

Although not shown in the figures, it should be understood that clampconnectors and strap connectors may have any configuration as long asthe clamp connectors and strap connectors engage with one another. Forexample, in an alternative embodiment, clamp connectors may comprise anopening within and/or through a surface of an endotracheal tube clampingmember (e.g., an opening within and/or through outer surface 104 ofendotracheal tube clamping member 92) and strap connectors may comprisea plurality of connectors in the form of mushroom-shaped membersextending outward from an outer surface of the strap (e.g., extendingoutward from outer surface 97 of strip material 93 of strap 91).

Straps used in the tube securing devices of the present invention (e.g.,strap 91) may be formed using a variety of materials. Suitable materialsinclude, but are not limited to, polymeric materials such asethylene-propylene copolymers, polyurethanes, and elastomeric polymers,as well as elastomeric materials such as natural and synthetic rubbermaterials. In one desired embodiment, the strap used in the tubesecuring devices of the present invention is formed using syntheticrubber material.

The present invention is further directed to methods of making airwaydevices and tube securing devices suitable for use in an endotrachealintubation procedure. In one exemplary embodiment, the present inventionis directed to a method of making an airway device (e.g., exemplaryairway device 50 or 60) comprising forming a tubular member 51 or 61having a proximal end 1, a distal end 6 opposite proximal end 1, atubular conduit 3 positioned between proximal end 1 and distal end 6,and a channel 31 extending from a first channel opening 35 at proximalend 1 through tubular conduit 3 to a second channel opening 34 proximatedistal end 6, wherein distal end 6 of device 50 or 60 has an overalldistal end width, d_(W), bound by opposing side walls 16 and 17, anoverall distal end height, d_(H), bound by an uppermost distal endsurface 13 and a lower distal end surface 14, and a tear-drop shaperepresented by uppermost distal end surface 13, lower distal end surface14, and a curved distal end surface 15 connecting uppermost distal endsurface 13 to lower distal end surface 14, wherein curved distal endsurface 15 extends substantially perpendicular to and between opposingside walls 16 and 17.

In one exemplary embodiment, the forming step comprises a singlethermoforming step (e.g., a single injection molding step), whereinthermoformable material is placed into the mold (e.g., injected) andmolded to form an airway device (e.g., exemplary airway device 50 or60). Suitable thermoformable materials for forming the disclosed airwaydevices include, but are not limited to, polyvinyl chlorides andpolyurethanes. In one desired embodiment, the thermoformable materialused to form the disclosed airway devices comprises a medical gradepolyvinyl chloride.

The method of making an airway device may further comprise one or moreadditional steps in addition to the thermoforming step. Suitableadditional method steps may include, but are not limited to, removingthe molded object (e.g., the airway device) from a mold, trimming anyexcess material from the airway device, coating the airway device with afinish on any outer surface (e.g., coating at least a portion of channel31 surface with a lubricant or slip agent), and forming a kit containingthe airway device and at least one other kit component. Desirably, themethod of making an airway device comprises a single thermoforming step(e.g., injection molding) without ant additional steps other thanpackaging the resulting device.

In a further exemplary embodiment, the method of making an airway device(e.g., exemplary airway device 60) comprises forming a tubular member 61having a proximal end 1, a distal end 6 opposite proximal end 1, atubular conduit 3 positioned between proximal end 1 and distal end 6, achannel 31 extending from a first channel opening 35 at proximal end 1through tubular conduit 3 to a second channel opening 34 proximatedistal end 6, and an epiglottis guard 30 extending along an upperportion 62 of tubular member 60. In this exemplary embodiment, theforming step may comprise a single thermoforming step (e.g., a singleinjection molding step as described above) or may comprise athermoforming step (e.g., for forming tubular member 61) in combinationwith one or more other method steps. For example, epiglottis guard 30may be formed by (i) a single molding step or (ii) in a separate stepcomprising cutting upper portion 62 of tubular member 61 extending overchannel 31 so as to form epiglottis guard 30 comprising (i) first end 63that is connected to tubular member 61 proximate second channel opening34, (ii) second end 64 that is not connected to tubular member 61 and ispositioned between second channel opening 34 and distal end 6, and (iii)opposing cut edges 65 and 66 extending from second end 64 to first end63, wherein second end 64 of epiglottis guard 30 is operatively adaptedto move into or away from channel 31, for example, during insertion ofendotracheal tube 8 through channel 31 of device 60 and into a patient'strachea 11.

In any of the above-described methods of forming an airway device, asingle thermoforming step (e.g., molding step) may be used to form oneor more fluid distribution channels 70 along lower distal end surface 14as described above. Any of the above-mentioned additional steps (otherthan the thermoforming step) may be used to further provide one or morefeatures to the resulting airway device.

The present invention is also directed to methods of making any of theabove-described tube securing devices (e.g., exemplary tube securingdevice 90). In one exemplary embodiment, the method of making a tubesecuring device (e.g., exemplary tube securing device 90) comprises (i)forming an endotracheal tube clamping member (e.g., exemplaryendotracheal tube clamping member 92), wherein the endotracheal tubeclamping member comprising at least one clamp connector (e.g., exemplaryclamp connector 105) positioned along an outer surface of theendotracheal tube clamping member; and (ii) forming a strap (e.g.,exemplary strap 91) comprising one or more strap connectors (e.g.,exemplary strap connectors 94) positioned along a length of the strap,wherein each of the one or more strap connectors are independentlyconnectable to a corresponding clamp connector (e.g., exemplary clampconnector 105).

In one exemplary embodiment, the step of forming an endotracheal tubeclamping member (e.g., exemplary endotracheal tube clamping member 92)comprises a single thermoforming step (e.g., a single injection moldingstep), wherein thermoformable material is placed into the mold (e.g.,injected) and molded to form an endotracheal tube clamping member (e.g.,exemplary endotracheal tube clamping member 92). As discussed above,thermoformable materials suitable for forming the disclosed endotrachealtube clamping member include, but are not limited to, polymericmaterials such as polyester, polypropylene, and polyvinyl chloride. Inone desired embodiment, the thermoformable material used to form thedisclosed endotracheal tube clamping member comprises polypropylene.

In one exemplary embodiment, the step of forming a strap (e.g.,exemplary strap 91) comprises a single thermoforming step (e.g., asingle extrusion step), wherein thermoformable material is extrudedthrough a die to form a sheet of strap material. As discussed above,thermoformable materials suitable for forming the disclosed strapinclude, but are not limited to, polymeric materials such asethylene-propylene copolymers, polyurethanes, and elastomeric polymers,as well as elastomeric materials such as natural and synthetic rubbermaterials. In one desired embodiment, the thermoformable material usedto form the disclosed strap comprises synthetic rubber material.

The method of making an endotracheal tube clamping member (e.g.,exemplary endotracheal tube clamping member 92) and/or a strap (e.g.,exemplary strap 91) may further comprise one or more additional steps inaddition to one or more thermoforming steps. Suitable additional methodsteps may include, but are not limited to, removing the molded object(e.g., exemplary endotracheal tube clamping member 92) from a mold,trimming any excess material from the endotracheal tube clamping memberor strap, coating the endotracheal tube clamping member or strap with afinish on any outer surface (e.g., coating at least a portion of innersurface 103 with an anti-slip agent), slitting an extruded sheet ofstrap material into strips of strap material having a desired strapwidth (S_(W)) and strap length (S_(L)), punching one or more openingsinto an outer surface of the endotracheal tube clamping member or strap,permanently fixing (e.g., via a single molding step) or temporarilyfixing (e.g., via a connection step) one end of the strap to theendotracheal tube clamping member, and forming a kit containing anendotracheal tube clamping member (e.g., exemplary endotracheal tubeclamping member 92) and a strap (e.g., exemplary strap 91) incombination with an airway device, an endotracheal tube, a combinationof an airway device and an endotracheal tube, and any other kitcomponent (e.g., a lubricant).

The present invention is further directed to methods of using theabove-described airway devices (e.g., exemplary airway device 50 or 60)and tube securing devices (e.g., exemplary tube securing device 90) inan endotracheal intubation procedure. In one exemplary embodiment, themethod of inserting an endotracheal tube 8 into a trachea 11 of apatient 44 comprises the steps of inserting an airway device (e.g.,exemplary airway device 50 or 60) into the patient's mouth 45 until acurved distal end surface 15 of the device abuts corniculate cartilage46 of the patient 44, wherein (1) the device comprises a tubular member51 or 61 having a proximal end 1, a distal end 6 opposite proximal end1, a tubular conduit 3 positioned between proximal end 1 and distal end6, and a channel 31 extending from a first channel opening 35 atproximal end 1 through tubular conduit 3 to a second channel opening 34proximate distal end 6, (2) distal end 6 has an overall distal endwidth, d_(W), bound by opposing side walls 16 and 17, an overall distalend height, d_(H), bound by an uppermost distal end surface 13 and alower distal end surface 14, and a tear-drop shape represented byuppermost distal end surface 13, lower distal end surface 14, and curveddistal end surface 15 connecting uppermost distal end surface 13 tolower distal end surface 14, and (3) curved distal end surface 15extends substantially perpendicular to and between opposing side walls16 and 17; and pushing endotracheal tube 8 through channel 31 of thedevice.

The exemplary method of using the above-described airway devices maycomprise one or more additional steps including, but not limited to,connecting a ventilation mask (not shown) to the proximal end 1 of thedevice after the inserting step; disconnecting the ventilation mask fromthe proximal end 1 of the device after the connecting step and prior tothe pushing step; coating at least a portion of a leading end 78 ofendotracheal tube 8 with a lubricant (not shown) prior to the pushingstep; and any combination of the above-mentioned steps.

In some embodiments of the present invention, the methods of using oneof the above-described airway devices further comprise a step ofsecuring a portion of an endotracheal tube extending from a patient'smouth to the patient via one of the above-described tube securingdevices of the present invention. An exemplary combination of an airwaydevice, an endotracheal tube, and a tube securing device suitable foruse in such a method is shown in FIG. 12.

As shown in FIG. 12, exemplary combination 120 comprises exemplary tubesecuring device 90 (as shown in FIG. 11) in combination withendotracheal tube 8 positioned within exemplary airway device 3 (asshown in FIG. 6). In exemplary combination 120, endotracheal tube 8extends through exemplary airway device 3 such that leading end 78 ofendotracheal tube 8 extends out of second channel opening 34 at distalend 6, forcing upward epiglottis guard 30. An opposite end 122 ofendotracheal tube 8 extends from proximate end 1 of exemplary airwaydevice 3. Exemplary tube securing device 90 is shown attached to aportion of endotracheal tube 8 proximate opposite end 122 with exemplaryendotracheal tube clamping member 92 of exemplary tube securing device90 clamped onto endotracheal tube 8 and exemplary strap 91 of exemplarytube securing device 90 attached to exemplary clamp connectors 105positioned on opposite sides of exemplary endotracheal tube clampingmember 92. As shown in FIG. 12, unused strap connectors 94 extend alonga length (S_(L)) of strap 91 and through strip material 93 from firstouter surface 98 to second (i.e., opposite) outer surface 97.

The present invention is further directed to a method of stabilizing aposition of an endotracheal tube inserted into a trachea of a patientusing a combination such as exemplary combination 120. In one exemplaryembodiment, the method comprises positioning an endotracheal tubeclamping member (e.g., exemplary endotracheal tube clamping member 92)of a tube securing device (e.g., exemplary tube securing device 90)around a portion of an outer surface of an endotracheal tube (e.g.,exemplary endotracheal tube 8) extending out of a patient's mouth so asto surround the portion of the endotracheal tube; clamping theendotracheal tube clamping member onto the portion of the endotrachealtube (e.g., via forcing pawling member 106 of exemplary endotrachealtube clamping member 92 onto row of teeth 109 as discussed above); andattaching at least one strap connector (e.g., strap connector 94) of astrap of the tube securing device (e.g., strap 91) to at least onecorresponding clamp connector (e.g., clamp connector 105) on theendotracheal tube clamping member (e.g., exemplary endotracheal tubeclamping member 92) so as to surround a portion of the patient's headand stabilize a position of the endotracheal tube relative to thepatient. Such a method is depicted in FIG. 13.

As shown in FIG. 13, opposite end 122 of endotracheal tube 8 extends outof proximate end 1 of exemplary airway device 3, both of which extendsout of the mouth 45 of patient 44. Exemplary endotracheal tube clampingmember 92 of exemplary tube securing device 90 is shown clamped ontoendotracheal tube 8 while exemplary strap 91 of exemplary tube securingdevice 90 is shown attached to exemplary clamp connectors 105 positionedon opposite sides of exemplary endotracheal tube clamping member 92 andextending around a portion of patient 44 (i.e., the head and/or neckregion of patient 44). Exemplary strap 91 may be positioned so as tocontact patient 44 along a rear head/neck region 110 as shown in FIG.13.

The above exemplary method of stabilizing a position of an endotrachealtube inserted into a trachea of a patient may comprise attaching a firststrap connector (e.g., exemplary strap connector 94) of the strap (e.g.,exemplary strap 91) to a first corresponding clamp connector (e.g.,exemplary clamp connector 105) on the endotracheal tube clamping member(e.g., exemplary endotracheal tube clamping member 92) prior to thepositioning step (i.e., the step of positioning an endotracheal tubeclamping member (e.g., exemplary endotracheal tube clamping member 92)of a tube securing device (e.g., exemplary tube securing device 90)around a portion of an outer surface of an endotracheal tube (e.g.,exemplary endotracheal tube 8) extending out of a patient's mouth so asto surround the portion of the endotracheal tube). The above exemplarymethod of stabilizing a position of an endotracheal tube inserted into atrachea of a patient may further comprise attaching a second strapconnector (e.g., exemplary strap connector 94) of the strap (e.g.,exemplary strap 91) to a second corresponding clamp connector (e.g.,exemplary clamp connector 105) on the endotracheal tube clamping member(e.g., exemplary endotracheal tube clamping member 92) after theclamping step (e.g., the step of clamping the endotracheal tube clampingmember onto the portion of the endotracheal tube) so as to surround theportion of the patient's head and stabilize the position of theendotracheal tube relative to the patient. Further, the positioning stepand the clamping step may occur prior to a step of inserting theendotracheal tube into the trachea of the patient.

The above-described airway devices and tube securing devices may each beprovided as an individual component or as one component in a kit forperforming an endotracheal intubation procedure. One exemplary kitcomprises at least one of the above-described airway devices incombination with an endotracheal tube. Another exemplary kit comprisesthe above-described tube securing device in combination with anendotracheal tube. A further exemplary kit comprises the above-describedtube securing device in combination with at least one of theabove-described airway devices. Yet a further exemplary kit comprisesthe above-described tube securing device in combination with at leastone of the above-described airway devices and an endotracheal tube.Another exemplary kit comprises kit components including, but notlimited to, at least one of the above-described airway devices, at leastone of the above-described tube securing devices, an endotracheal tube,a lubricant, a ventilation mask, or any combination thereof.

In one exemplary embodiment, a given kit comprises at least one of theabove-described tube securing devices in combination with an airwaydevice, wherein the airway device comprises a tubular member having aproximal end, a distal end opposite the proximal end, a tubular conduitpositioned between the proximal end and the distal end, and a channelextending from a first channel opening at the proximal end through thetubular conduit to a second channel opening proximate the distal end;the distal end having an overall distal end width bound by opposing sidewalls, an overall distal end height bound by an uppermost distal endsurface and a lower distal end surface, and a tear-drop shaperepresented by the uppermost distal end surface, the lower distal endsurface, and a curved distal end surface connecting the uppermost distalend surface to the lower distal end surface, the curved distal endsurface extending substantially perpendicular to and between theopposing side walls.

In another exemplary embodiment, a given kit comprises at least one ofthe above-described tube securing devices in combination with an airwaydevice, wherein the airway device comprises a tubular member having aproximal end, a distal end opposite the proximal end, a tubular conduitpositioned between the proximal end and the distal end, and a channelextending from a first channel opening at the proximal end through thetubular conduit to a second channel opening proximate the distal end,and an epiglottis guard extending along an upper portion of the tubularmember, the epiglottis guard comprising (i) a first end that isconnected to the tubular member proximate the second channel opening,(ii) a second end that is not connected to the tubular member andpositioned between the second channel opening and the distal end, and(iii) opposing edges extending from the first end to the second end, theopposing edges being not connected to the tubular member, wherein thesecond end is operatively adapted to move into or away from the channel.

In a further exemplary embodiment, a given kit comprises a tube securingdevice in combination with an airway device, wherein the tube securingdevice comprises (1) an endotracheal tube clamping member operativelyadapted to clamp onto an outer surface of an endotracheal tube, theendotracheal tube clamping member comprising (i) a closed end having aclosed end inner surface and a closed end outer surface, (ii) an openend opposite the closed end and comprising (iii) a pawling member and(iv) a ratcheting member, the pawling member being movable along a rowof ratcheting teeth along the ratcheting member so as to lock thepawling member within the ratcheting member and simultaneously clamponto the outer surface of the endotracheal tube, and (v) a pair of clampconnectors positioned along opposite sides of the closed end outersurface, wherein each of the clamp connectors comprises amushroom-shaped member extending outward from opposite sides of theclosed end outer surface; and (2) a strap comprising (i) a strip ofmaterial having opposite strip ends, a strip width, and a strip lengthextending between the opposite strip ends, and (ii) a plurality of strapconnectors positioned along the strip length, each of the one or morestrap connectors being independently connectable to a correspondingclamp connector, wherein each strap connector comprises an openingextending through the strap.

The present invention is described above and further illustrated belowby way of examples, which are not to be construed in any way as imposinglimitations upon the scope of the invention. On the contrary, it is tobe clearly understood that resort may be had to various otherembodiments, modifications, and equivalents thereof which, after readingthe description herein, may suggest themselves to those skilled in theart without departing from the spirit of the present invention and/orthe scope of the appended claims.

EXAMPLE 1

An airway device was formed via an injection molding step in whichmedical grade polyvinyl chloride was molded into a shape as shown inFIGS. 1-3. The resulting airway device had the following dimensions:

length=16.5 cm (6.5 in)

width of distal end=3.49 cm (1.375 in)

height of distal end=2.22 cm (0.875 in)

inner diameter=2.22 cm (0.875 in)

outer diameter=3.18 cm (1.25 in)

length of depth indicator ring=2.86 cm (1.125 in)

tubular conduit wall thickness=0.48 cm (0.1875 in)

angle of curvature along device=140°

angle of inclination along distal end of device=40°.

EXAMPLE 2

An airway device was formed via an injection molding step in whichmedical grade polyvinyl chloride was molded into a shape as shown inFIGS. 6-9. The resulting airway device had the following dimensions:

length=14.5 cm (5.7 in)

width of distal end=3.65 cm (1.438 in)

height of distal end=4.44 cm (1.75 in)

inner diameter=1.59 cm (0.625 in)

outer diameter=2.22 cm (0.875 in)

length of depth indicator ring=1.11 cm (0.438 in)

tubular conduit wall thickness=0.32 cm (0.125 in)

angle of curvature along device=135°

angle of inclination along distal end of device=30°

length of epiglottis guard (g_(L))=3.18 cm (1.25 in).

EXAMPLE 3

A tube securing device was formed. An endotracheal tube clamping member(e.g., exemplary endotracheal tube clamping member 92) was formed via aninjection molding step in which polypropylene was molded into a shape asshown in FIGS. 11-13. The resulting endotracheal tube clamping memberhad the following dimensions and features:

length=3.49 cm (1.375 in)

width of closed end=2.38 cm (0.937 in)

width of open end=1.59 cm (0.625 in)

height of member=1.11 cm (0.437 in)

inner diameter of closed end=1.11 cm (0.437 in)

outer diameter of closed end=1.59 cm (0.625 in)

length of each clamp connector=0.38 cm (0.150 in)

diameter of a given clamp connector stem portion=0.32 cm (0.125 in)

overall diameter of a given clamp connector=0.83 cm (0.325 in)

approximate number of teeth in row of teeth=9.

A strap (e.g., exemplary strap 91) was formed via an extrusion step inwhich synthetic rubber material was extruded into a shape as shown inFIGS. 11-13. The resulting strap had the following dimensions andfeatures:

length=55.2 cm (21.75 in)

width=1.9 cm (0.75 in)

thickness=0.06 cm (0.025 in)

total number of strap connectors=10.

The resulting tube securing device was used in combination with theairway device of Example 1 and the airway device of Example 2 as shownin FIGS. 12-13.

While the specification has been described in detail with respect tospecific embodiments thereof, it will be appreciated that those skilledin the art, upon attaining an understanding of the foregoing, mayreadily conceive of alterations to, variations of, and equivalents tothese embodiments. Accordingly, the scope of the present inventionshould be assessed as that of the appended claims and any equivalentsthereto.

1. A tube securing device for stabilizing a position of an endotrachealtube on a patient, said tube securing device comprising: an endotrachealtube clamping member operatively adapted to clamp onto an outer surfaceof an endotracheal tube, said endotracheal tube clamping membercomprising at least one clamp connector positioned along an outersurface of said endotracheal tube clamping member; and a strapcomprising one or more strap connectors positioned along a length ofsaid strap, each of said one or more strap connectors beingindependently connectable to a corresponding clamp connector.
 2. Thetube securing device of claim 1, wherein said endotracheal tube clampingmember comprises a closed end having a closed end inner surface and aclosed end outer surface, an open end opposite said closed end andcomprising a pawling member and a ratcheting member, said pawling memberbeing movable along a row of ratcheting teeth along said ratchetingmember so as to lock said pawling member within said ratcheting memberand simultaneously clamp onto the outer surface of the endotrachealtube.
 3. The tube securing device of claim 2, wherein said endotrachealtube clamping member comprises a pair of clamp connectors positionedalong opposite sides of said closed end outer surface.
 4. The tubesecuring device of claim 3, wherein each of said clamp connectorscomprises a mushroom-shaped member extending outward from opposite sidesof said closed end outer surface.
 5. The tube securing device of claim1, wherein said strap comprising a strip of material having oppositestrip ends, a strip width, a strip length extending between saidopposite strip ends, and a plurality of strap connectors positionedalong said strip length, wherein said strip length is about 10 or moretimes greater than said strip width.
 6. The tube securing device ofclaim 5, wherein each strap connector comprises an opening extendingthrough said strap.
 7. The tube securing device of claim 5, wherein saidmaterial comprises a polymeric material or an elastomeric material. 8.The tube securing device of claim 5, wherein said strip width rangesfrom about 1.2 cm to about 2.5 cm, and said strip length ranges fromabout 38.1 cm to about 63.5 cm.
 9. A kit comprising: the tube securingdevice of claim 1; and an airway device.
 10. The kit of claim 9, whereinsaid airway device comprises: a tubular member having a proximal end, adistal end opposite the proximal end, a tubular conduit positionedbetween the proximal end and the distal end, and a channel extendingfrom a first channel opening at the proximal end through the tubularconduit to a second channel opening proximate the distal end; saiddistal end having an overall distal end width bound by opposing sidewalls, an overall distal end height bound by an uppermost distal endsurface and a lower distal end surface, and a tear-drop shaperepresented by the uppermost distal end surface, the lower distal endsurface, and a curved distal end surface connecting the uppermost distalend surface to the lower distal end surface, said curved distal endsurface extending substantially perpendicular to and between saidopposing side walls.
 11. The kit of claim 9, wherein said airway devicecomprises: a tubular member having a proximal end, a distal end oppositethe proximal end, a tubular conduit positioned between the proximal endand the distal end, and a channel extending from a first channel openingat the proximal end through the tubular conduit to a second channelopening proximate the distal end; and an epiglottis guard extendingalong an upper portion of said tubular member, said epiglottis guardcomprising (i) a first end that is connected to said tubular memberproximate said second channel opening, (ii) a second end that is notconnected to said tubular member and positioned between said secondchannel opening and said distal end, and (iii) opposing edges extendingfrom said first end to said second end, said opposing edges being notconnected to said tubular member, wherein said second end is operativelyadapted to move into or away from said channel.
 12. A method ofstabilizing a position of an endotracheal tube inserted into a tracheaof a patient, said method comprising: positioning the endotracheal tubeclamping member of the tube securing device of claim 1 around a portionof the outer surface of the endotracheal tube extending out of thepatient's mouth so as to surround the portion of the endotracheal tube;clamping the endotracheal tube clamping member onto the portion of theendotracheal tube; and attaching at least one of the strap connectors ofthe strap of the tube securing device to at least one correspondingclamp connector on the endotracheal tube clamping member so as tosurround a portion of the patient's head and stabilize a position of theendotracheal tube relative to the patient.
 13. The method of claim 12,further comprising: attaching a first strap connector of said strap to afirst corresponding clamp connector on said endotracheal tube clampingmember prior to said positioning step; and attaching a second strapconnector of said strap to a second corresponding clamp connector onsaid endotracheal tube clamping member after said clamping step so as tosurround the portion of the patient's head and stabilize the position ofthe endotracheal tube relative to the patient.
 14. A tube securingdevice for stabilizing a position of an endotracheal tube extending froma patient's mouth, said tube securing device comprising: an endotrachealtube clamping member operatively adapted to clamp onto an outer surfaceof an endotracheal tube, said endotracheal tube clamping membercomprising: a closed end having a closed end inner surface and a closedend outer surface, an open end opposite said closed end and comprising apawling member and a ratcheting member, said pawling member beingmovable along a row of ratcheting teeth along said ratcheting member soas to lock said pawling member within said ratcheting member andsimultaneously clamp onto the outer surface of the endotracheal tube,and a pair of clamp connectors positioned along opposite sides of saidclosed end outer surface, wherein each of said clamp connectorscomprises a mushroom-shaped member extending outward from opposite sidesof said closed end outer surface; and a strap comprising: a strip ofmaterial having opposite strip ends, a strip width, and a strip lengthextending between said opposite strip ends, and a plurality of strapconnectors positioned along said strip length, each of said one or morestrap connectors being independently connectable to a correspondingclamp connector, wherein each strap connector comprises an openingextending through said strap.
 15. The tube securing device of claim 14,wherein said strip length enables said strap to extend from thepatient's mouth, along a rear portion of the patient's head or neckregion, and back to the patient's mouth so as to surround a portion ofthe patient's head.
 16. The tube securing device of claim 14, whereinsaid endotracheal tube clamping member is formed from polypropylene, andsaid strip is formed from a synthetic rubber material.
 17. A kitcomprising: the tube securing device of claim 15; and an airway device.18. The kit of claim 17, wherein said airway device comprises: a tubularmember having a proximal end, a distal end opposite the proximal end, atubular conduit positioned between the proximal end and the distal end,and a channel extending from a first channel opening at the proximal endthrough the tubular conduit to a second channel opening proximate thedistal end; and an epiglottis guard extending along an upper portion ofsaid tubular member, said epiglottis guard comprising (i) a first endthat is connected to said tubular member proximate said second channelopening, (ii) a second end that is not connected to said tubular memberand positioned between said second channel opening and said distal end,and (iii) opposing edges extending from said first end to said secondend, said opposing edges being not connected to said tubular member,wherein said second end is operatively adapted to move into or away fromsaid channel.
 19. A kit comprising: the tube securing device of claim15; and an endotracheal tube.
 20. A kit comprising: a tube securingdevice for stabilizing a position of an endotracheal tube on a patient,said tube securing device comprising: an endotracheal tube clampingmember operatively adapted to clamp onto an outer surface of anendotracheal tube, said endotracheal tube clamping member comprising atleast one clamp connector positioned along an outer surface of saidendotracheal tube clamping member; and a strap comprising one or morestrap connectors positioned along a length of said strap, each of saidone or more strap connectors being independently connectable to acorresponding clamp connector; and an airway device, wherein said airwaydevice comprises: a tubular member having a proximal end, a distal endopposite the proximal end, a tubular conduit positioned between theproximal end and the distal end, and a channel extending from a firstchannel opening at the proximal end through the tubular conduit to asecond channel opening proximate the distal end; and an epiglottis guardextending along an upper portion of said tubular member, said epiglottisguard comprising (i) a first end that is connected to said tubularmember proximate said second channel opening, (ii) a second end that isnot connected to said tubular member and positioned between said secondchannel opening and said distal end, and (iii) opposing edges extendingfrom said first end to said second end, said opposing edges being notconnected to said tubular member, wherein said second end is operativelyadapted to move into or away from said channel.